Flushable body waste collection pouch, pouch-in-pouch appliance using the same, and method relating thereto

ABSTRACT

A biodegradable and toilet-flushable body waste collection pouch, and an appliance in which such pouch constitutes the inner pouch of a peelably separable pouch-in- pouch system, are disclosed. The walls of the inner pouch are composed of an ultra-thin, heat-sealable film impermeable to body wastes comprising a plasticized biodegradable polyester or copolyester externally covered by a soft, porous, water-disintegratable cover layer of biodegradable and water-dispersible fibers.

RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication Ser. No. 60/512,759 filed Oct. 21, 2003 and Danish PatentApplication Serial No. 2003/01550, filed Oct. 21, 2003.

BACKGROUND AND SUMMARY

This invention relates to flushable body waste collection pouches, andparticularly to a biodegradable pouch suitable for use as thetoilet-disposable inner pouch of a pouch-within-a-pouch ostomy applianceof the type generally disclosed in U.S. Pat. No. 5,865,819 and incopending U.S. Pat. Appl 10/969,523 claiming priority from provisionalapplication 60/512,760 filed Oct. 21, 2003 and bearing the name ofClaudio Giori as a co-inventor. The disposable pouch has a pair of wallssecured together along their peripheral edges to define awaste-receiving chamber, and one of the side walls has a body wastereceiving opening which communicates with that chamber. Externalattachment means are provided about the opening for attachment of thepouch (or pouch assembly) to a wearer.

The only inner pouch currently on the market is a pouch available fromWelland Medical covered by U.S. Pat. No. 5,938,647. This pouch is madeof hot water soluble polyvinylalcohol. The problem with polyvinylalcoholis that it becomes brittle and noisy upon aging and has limitedbiodegradability. Thus, there is a need for an inner pouch file that isflexible, water impermeable, has low noise (an important requirement forostomy and fecal incontinence pouches) and good biodegradability.

The walls of a pouch embodying this invention are composed of a thin,heat sealable (including RF sealable) and liquid-impermeable monolayerfilm of a composition comprising a plasticized biodegradable aliphaticpolyester, or a plasticized biodegradable aliphatic-aromaticcopolyester, or blends thereof, covered by a water-disintegratable layerof biodegradable and water-dispersible fibers, most preferablycellulosic fibers, bonded thereto. The polyester or copolyester isblended with an aliphatic ester plasticizer such as triethylcitrate orvegetable oil. Such a plasticizer imparts greater flexibility to thefilm, reduces film noise upon wrinkling, and allows extrusion of theresin into films or coatings as thin as 10 microns (0.8 mil) or less. Ithas also been found that the presence of the plasticizer effectivelyincreases the rate of biodegradation of the film. Starch may also beused advantageously as a biodegradable plasticizer.

The composition of the film may comprise a blend of about 70% to 95% byweight of the biodegradable aliphatic polyester or aliphatic-aromaticcopolyester and 5% to 30% of a biodegradable plasticizer orplasticizers. More desireably, the blend is within the range of about75% to 93% polyester or copolyester and about 7% to 25% plasticizer(s).A preferred composition is believed to be about 90% polyester orcopolyester and about 10% plasticizer(s).

The aliphatic polyester may comprise a polymer made by ring-openingpolymerization of a lactone, preferably polycaprolactone. Thealiphatic-aromatic copolymer may comprise a condensation product of aglycol with a combination of an aliphatic diacid and aromatic diacid,wherein the aromatic diacid is less than 20% by mole.

To enhance biodegrability, minimize noise, and reduce cost, the filmshould be ultra-thin, having a thickness no greater than about 40microns (1.57 mil). A preferred thickness range is believed to be about6 to 40 microns (0.24 to 1.57 mil) with a more preferred range beingabout 10 to 35 microns (0.39 to 1.38 mil). Particularly effectiveresults are believed to occur when the thickness range is about 15 to 30microns (0.59 to 1.18 mil).

The ultra-thin monolayer film, having the advantages and featuresdescribed above, is reinforced by the water-disintegratable cover layerdefining the outer surfaces of the pouch. The cover layer is composed ofa random arrangement of water-dispersible fibers, has nonon-water-soluble binder (and preferably no binder at all) and hassignificant dry strength with virtually no elongation but lacks wetstrength. Tissue paper having a high cellulosic fiber content,preferably 100%, is believed particularly effective. The monolayer filmmay be secured uninterruptedly throughout one of its side surfaces tothe tissue or other reinforcing substrate by any suitable means. Whileadhesive attachment (as by a water-soluble and biodegradable adhesive)is considered feasible, it is believed more effective to extrude thepolyester or copolyester onto the paper substrate to form a thin butuninterrupted coating thereon or to laminate the two layers togetherwith heat, with the attachment between the opposing surfaces of the twolayers in either case being produced with heat and being mechanical innature. As long as the external surface of the pouch is in a dry state,the tissue paper covering offers mechanical strength, softness, andnoise reduction but, upon exposure to water, as when the pouch isdiscarded into a flush toilet, the tissue disintegrates rapidly and isbelieved to contribute to flushability by rapidly absorbing water,wetting the film surface, and reducing pouch buoyancy.

An important aspect of this invention lies in the strength, or lack ofstrength, of the attachment between substantially one entire surface ofthe cover layer (excluding its peripheral edge portions) and the filmthat together form each wall of the flushable pouch. (It is along suchperipheral edge portions that the layers are securely heat-sealedtogether to form a completed pouch.) To avoid the formation ofunacceptable pinholes in the film, it is essential that none of thefibers of the cover layer extends through the film or even penetratesthe film to any appreciable extent. Since the film may be any of anumber of different thicknesses, but is ultra-thin in any event,measuring the maximum extent of penetration, if any, is not consideredfeasible. However, it has been found that no appreciable penetration isachieved, and no pinholes are formed, if the extent of bonding betweenthe paper and film layers is such that the two layers may be peeled awayfrom each other (when dry), with both layers remaining intact, by theapplication of 180-degree peel forces in the range of about 2 to 10 g/in(0.02 to 0.1 Newtons/in), preferably about 3 to 6 g/in (0.03 to 0.06Newtons/in). Under such conditions, the layers are found to be bondedtogether with sufficient strength to maintain the integrity of the pouchwall during use but without risk of unacceptable fiber penetration.

Since the polyester or copolyester films are heat sealable (including RFsealable), the films may be readily converted into pouches usingconventional heat sealing methods. Although the film is covered by asoft, flexible and fibrous backing layer as described above, heatsealing is nevertheless readily achieved because the polymeric layers ofthe pouch walls face inwardly and may therefore be securely welded toeach other. Where the pouch serves as the inner pouch of a two-pouchsystem, it has been found that where the inner pouch has a fibrous andporous cover layer of tissue paper or other suitable fibrous and poroussubstrate, heat sealing between the film of the inner pouch, the fibrousand porous cover layer, and the film of the outer pouch, as along theperipheral edges of the two pouches, may nevertheless occur. In such acase, the seal between the walls of the outer pouch and the fibrouslayer of the inner pouch walls is weaker than the seal between the twowalls of the inner pouch, thereby allowing the outer pouch to be torn orpeeled away from the inner pouch without adversely affecting theintegrity of the inner pouch, at which time the still-intact inner pouchand its contents may be discarded into the water of a toilet bowl tocommence the disintegration and biodegradation process.

In such a pouch-in-pouch appliance, where the walls of the flushableinner pouch are composed of thermoplastic film and tissue paper layersweakly bonded together, it is essential that peeling away of the outerpouch not cause delamination of the paper and film layers of the innerpouch since, as already noted, the paper layer is believed to contributesignificantly to the flushability of the inner pouch. Also, retention ofthe soft paper layer by the inner pouch provides tactile benefits forthe user who must handle and remove the inner pouch for toilet disposal,as well as assuring the user that the step of peeling away of the outerpouch walls has not compromised the integrity of the inner pouch. Animportant aspect of this invention therefore lies in avoiding the risksof such delamination by selecting a thermoplastic material for the outerpouch that has a melting temperature greater than that of thethermoplastic material of the inner pouch. Since the fibers of thenon-thermoplastic cover layer penetrate the thermoplastic films of bothpouches in the zone of the peripheral heat seal, and since thethermoplastic material of the inner pouch has a lower meltingtemperature, the fiber penetration into the film of the inner pouchalong the peripheral heat seal is greater than into the film of theouter pouch and insures that the paper layer will preferentially remainwith the inner pouch as the walls of the outer pouch are peeled away.

The peripheral heat seal therefore simultaneously joins the multiplelayers together in different ways to achieve peelability of the outerpouch walls away from the fibrous cover layer of the inner pouch, theretention of the fibrous cover layer by the inner pouch, and the trueheat-sealing or welding together of the walls of the inner pouch alongtheir peripheral edges.

Other features and advantages of the invention will become apparent asthe specification proceeds.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an elevational view of a flushable body waste collection pouchembodying the invention.

FIG. 2 is a somewhat-schematic vertical sectional view taken along line2—2 of FIG. 1.

FIG. 3 is a sectional view similar to FIG. 2 but showing the flushablepouch as the inner pouch of a pouch-in-pouch appliance.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The polyester or copolyester film material of an ostomy pouch or fecalincontinence pouch embodying this invention is obtained by chemicalsynthesis rather than by a fermentation process. Polyester orcopolyester films produced by a fermentation process are consideredunsuitable because they tend to be brittle and cannot be converted intothin flexible films. Examples of synthetic biodegradable polyesters arealiphatic polyesters such as polycaprolactone (“Tone” from Dow Chemical)and aliphatic-aromatic copolyesters with less than 20% by mole ofaromatic diacid component (“Estar Bio” from Eastman Chemical, “Ecoflex”from BASF). A synthetic biodegradable polyester precompounded withbiodegradable plasticizers and suitable for thin film extrusion isavailable commercially from Petroplast Vinora under the designation“KF02B”.

Referring to FIGS. 1 and 2 of the drawings, the numeral 10 generallydesignates a toilet-flushable body waste collection pouch with proximal(rear or bodyside) and distal (front) walls 11 and 12 having theirperipheral edges joined together along a heat seal zone 13. For purposesof illustration, an ostomy pouch is shown, but the invention isapplicable to other body waste collection pouches such as fecalincontinence pouches. Also, the terms “heat seal” and “heat sealing”should here be understood to include other forms of thermoplasticwelding such as RF sealing. As shown, the proximal or bodyside wall isprovided with an opening 14 communicating with the chamber 15 of thepouch.

The appliance 10 includes a faceplate 17 having a soft, pliant adhesivelayer 18 for adhesive attachment to the peristomal skin surfaces of awearer. A cover film 19 extends over the pouch-facing surfaces of thefaceplate's adhesive layer 18, and a stoma-receiving opening 20 isprovided in the faceplate in alignment with the opening 14 in the pouch.Attachment means 21 is schematically illustrated in FIG. 2 for joiningthe faceplate and pouch together. Such attachment means may take theform of a releasable mechanical coupling or a separable adhesive seal,all as well known in the art. For purposes of this embodiment of theinvention, which focuses on pouch 10 and the materials from which it isformed (and the combination of that pouch with an outer pouch 10′), theattachment 21 is critical only to the extent that there must be somemeans around the stoma-receiving opening 14 for securing the pouch to awearer.

Pouch 10 has its walls 11 and 12 formed of an ultra-thin heat-sealable(including RF sealable) liquid and gas impermeable film 23 externallybonded to a thin water-disintegratable cover layer 24. As previouslystated, the film 23 is of a composition comprising a biodegradable,thermoplastic and heat-sealable, aliphatic polyester, oraliphatic-aromatic copolyester, or blends thereof, combined with abiodegradable plasticizer or combination of such plasticizers. The soft,flexible, water disintegratable cover layer 24 is composed of a randomarrangement of water-dispersible non-thermoplastic fibers, preferablycellulosic fibers, and has significant tensile strength when dry butlacks such strength when wet, all as already described. The two layersare mechanically bonded together, preferably by heat, in such a way thatdespite the ultra-thin character of the film and the fibrous nature ofthe cover layer, there is no significant penetration of the fibers intothe film and no formation of pinholes through the film. While some verylimited penetration of the fibers into the film may exist to produce theweak mechanical bond between the layers, the penetration is so slightand the bonding forces so weak that the two layers (when dry) may beeasily peeled apart with each layer remaining intact during andfollowing such a peeling operation. More specifically, the mechanicalattachment between the film and cover layer must be sufficiently weak toallow separation by the application of a 180 degree peeling force ofabout 2 to 10 g/in (0.02 to 0.1 Newtons/in), preferably about 3 to 6g/in (0.03 to 0.06 Newtons/in), when tested in accordance with TAPPITest Method UM502 (1991), all with little or no evidence of fiberretention by the film. Under such circumstances, the separated film willbe free of pinholes that might otherwise cause fluid (liquid) leakage ofthe laminated two-layer product in use.

The water-disintegratable cover layer of non-thermoplasticwater-dispersible fibers also plays an important role when the pouchserves as the inner pouch of a two-pouch (pouch-in-pouch) appliance asshown in FIG. 3. As there shown, pouch 10 is disposed within the chamber15′ of an outer pouch 10′. The peripheral edge portions of the twopouches may be joined together by heat sealing 13′ which should beunderstood here to include RF sealing. The outer pouch 10′ is ofconventional construction and composed of any of a variety of knownthermoplastic film materials that have a sufficiently high heat sealingor melting temperature and that are impermeable to liquids, gases andodors. It includes a proximal (rear or bodyside) wall 11′ and a distal(front) wall 12′ with the proximal wall having a stoma-receiving opening14′ aligned with the corresponding opening 14 of the inner pouch. Thetwo pouches are sealed together, as by heat seal 30, about theirrespective openings. Therefore, body waste passing into the appliancecan only enter the inner pouch and not the space between the twopouches.

As brought out in the aforementioned copending application, thedisclosure of which is incorporated by reference herein, the peripheralseal 13′ and the seal 30 about stoma openings 14, 14′ are peelable sealsthat allow the proximal and distal walls 11′ and 12′ of the outer pouchto be peeled away from the inner pouch without disrupting the integrityof the peripheral seal that holds the walls of the inner pouch together.Thus, the walls of the outer pouch may be peeled away to expose thebiodegradable inner pouch 10 so that the latter may be discarded alongwith its contents into a flush toilet. The outer pouch 10′, which may ormay not be biodegradable, may then be placed into any suitable wastereceptacle.

As already noted, the fibrous and porous water-disintegratable layer 24and the film layer 23 that together form the walls of the inner pouchhave their major surfaces areas only weakly bonded together, allowingthem to be separated intact from each other with the application of onlylimited peeling force. However, that does not include the peripheralheat seal zone 13′ of the pouch shown in FIG. 3, where the film layers23 of the inner pouch are securely heat sealed or welded to each otherand also penetrate the pores of the peripheral zones of the fibrouslayers 24 to produce a secure bond with the fibrous layers along theperiphery of the inner pouch. The peripheral zones of the fibrous layersare also penetrated to at least some extent by the heat sealablematerial forming the walls 11′ and 12′ of the outer pouch 10′. However,the strength of the bond in the peripheral zones between the fibrouslayers and the films of the inner pouch is much greater than between thefibrous layers and the thermoplastic films forming the walls of theouter pouch because the melting temperature of the inner pouch filmmaterial is substantially lower than the melting temperature of theouter pouch film material. The result is that when a user peels away thewalls of the outer pouch to expose the inner pouch, thewater-disintegratable, non-heat-sealable tissue paper layers of theinner pouch remain as part of the inner pouch and are not stripped awaywith the walls of the outer pouch.

Differential scanning calorimetry (DSC) can be used to measure themelting point of candidate film materials and to predict if a certaincombination of films might be suitable for the inner and outer pouches.For example, it has been found that a biodegradable plasticizedpolyester available from Petroplast Vinora under the designation KF02Bhas a DSC melting peak of 65 degrees C. A known multilayer barrier filmcurrently used commercially for ostomy pouches has a heat-sealable skinlayer of poly(ethylene vinylacetate) (EVA) with a DSC melting peak of 88degrees C. Because of this difference in melting temperatures, it ispossible to control heat sealing conditions so that the tissue layer inthe peripheral areas of the pouch walls exhibits a stronger bond withthe inner pouch film than with the outer pouch film following a heatsealing operation (including RF sealing). As a result, the outer pouchcan be peeled away without causing separation of the tissue layer fromthe inner pouch film. A melting temperature differential of at least 10degrees C. is believed to be needed to control layer separation.

To facilitate the step of manually peeling away the proximal and distalwalls of outer pouch 10′, such walls may be provided with gripping tabs(not shown) that project outwardly beyond the peripheral edges of innerpouch 10.

The walls of the inner pouch must be impermeable to fluid and solid bodywastes, and the biodegradable plasticized polyesters or copolyestersdescribed herein perform that function well. Biodegradable polyesters orcopolyesters, while generally considered gas impermeable, neverthelessallow diffusion of odors to an extent that renders them, without someprotective means, unsuitable for body waste collection pouches intendedfor more than extremely short durations of use. A plasticizedbiodegradable polyester or copolyester pouch in the condition shown inFIGS. 1 and 2 is therefore useful for periods substantially shorter thanone hour as, for example, as a pouch to be used with stomal implantswhere the duration of use may be 30 minutes or less. Despite the odorpermeability of such biodegradable polyester materials, however, pouchesformed therefrom are well suited for long term body waste collection ifthey are used for the inner pouches of two pouch systems, as shown inFIG. 3, with odor impermeability then provided by the protective outerpouches. Any of a variety of well-known heat-sealable pouch materialsthat are odor impermeable are suitable for fabrication of outer pouch10′ which is not intended to be toilet flushable.

As described above, cover layer 24 of inner pouch 10 is of a porousmaterial that is supportive when dry but has low wet strength. It shouldalso be soft and flexible. Tissue paper that has a high percentage(preferably 100%) of cellulosic fibers is preferred such as, forexample, a cellulosic tissue paper of the type available from ShawanoSpecialty Papers having a basis weight of 14 lb/ream. Absence of abinder is desirable because a binder may interfere with or retard therate of disintegration, but a limited amount of a binder that isnon-thermoplastic and readily soluble or disintegratable in water, suchas starch, may be acceptable. The porous tissue layer for each wall 11and 12, when such layer is in a dry state, provides reinforcement,softness, and noise reduction for the thin thermoplastic film of theinner pouch and is believed to contribute to the flushability of thefilm when the inner pouch is separated from the outer pouch anddiscarded into a flush toilet.

As believed evident from the above, the method of making apouch-in-pouch waste collection appliance embodying this inventioninvolves the steps of selecting a thermoplastic material for the film ofthe inner pouch that has a melting temperature substantially lower thanthat of the thermoplastic material for the film of the outer pouch andthen joining together peripheral portions of the walls of the twopouches by simultaneously applying pressure and heat so that the filmmaterial of the inner pouch melts and invades the pores of the fibrouscover layer to a greater extent than the film material of the outerpouch. At the same time, the opposing or inwardly-facing film layers ofthe inner pouch become fused to each other, forming a true heat seal orweld between the walls of the inner pouch. Upon the subsequentapplication of peeling forces, the walls of the outer pouch may then bepeeled away from those of the inner pouch without causing separation ofthe porous cover layer and film layer of the inner pouch and withoutdisrupting the integrity of the inner pouch. The exposed inner pouch andits contents are then discarded into a flush toilet.

It will be noted from FIG. 3 that the proximal wall of the outer pouchmay be similarly joined to the porous cover layer of the proximal wallof the inner pouch around the stoma-receiving opening so that as theproximal wall of the outer pouch is peeled away from the proximal wallof the inner pouch, that is, when the inner pouch is extracted from whatremains of the cavity of the outer pouch, a clean separation will occurwith the porous cover layer again being retained as part of theflushable inner pouch.

Other features and advantages of the invention will become apparent fromthe following examples:

EXAMPLE 1

Two methods are particularly suitable for the production of thetissue/film laminate of pouch 10: (1) extrusion coating onto tissuepaper (1 step), and (2) film extrusion followed by lamination of thefilm to tissue paper (2 steps). Extrusion coating may be accomplishedusing a Davis Standard extrusion coating line. Tissue paper is used as asubstrate and the biodegradable polyester is directly extruded onto thetissue in a single step process. With a two-step process, film may befirst extruded using a blown film extrusion line and then laminated topaper tissue paper using a Faustel laminator. Lamination is ideallyaccomplished thermally with no adhesive layer between tissue and film.Both processes (1) and (2) give high quality laminates with no wrinklesor other defects. A two-step process is preferred because it affordsbetter control of the adhesion and interpenetration between tissue andfilm. A temperature in the 165° to 220° F. range and a nip pressure inthe 40–50 psi range are typically used for lamination. It is from such alaminate that the walls of the pouch may then be die-cut.

EXAMPLE 2

Blends of polycaprolactone (“Tone 787” from Dow Chemical) andtriethylcitrate (“Citroflex 2” from Morflex Corp.) were compounded andpelletized using a twin-screw compounder extruder. The compoundedpellets were converted into film using a cast film line equipped with a1.25 inch extruder having an L/D ratio of 24:1. Film was extruded at adie temperature of 320° F. The following table illustrates the effect ofplasticizer content on tensile modulus and noise at a film thickness of0.6 mil (15.2 microns):

Effect of Triethylcitrate Content (TEC) on Tensile Modulus and Noise ofPolycaprolactone (PCL) PCL Unplasticized PCL, 10% TEC PCL, 20% TECTensile modulus, 48200 25600 9950 psi(*) Noise(**) dBA 69 65 55 dB. 8kHz 56 51 41 (*)Secant modulus at 2% elongation, ASTM D882 (initialstrain rate: 10 in/in min) (**)Film sample is formed into a cylinder andmounted on a test fixture wherein one end is held fixed and the other isrotated around the cylinder axis (15 degree angle, 70 cycles/min). Noiseemissions from film flexing are analyzed with a sound level meter. dBAis a weighted average which takes into account the human perception ofnoise over the entire frequency range, dB in the 8 kHz octave band isindicative of the noise in the high frequency range andrepresents thecrispness of the noise.

The data in this table shows that increasing triethylcitrate plasticizercontent reduces the modulus of the polycaprolactone film (i.e.,increases its flexibility) and reduces the noise of the film. At 20%TEC, however, film blocking, (where the surfaces of adjacent films sticktogether) becomes a problem. A plasticizer level of 10% is preferredbecause it provides adequate flexibility and quietness without blocking.

EXAMPLE 3

As ostomy pouch suitable for use as the inner pouch of a two-pouchappliance was constructed with a thin, plasticized polycaprolactone filmof 0.2 to 0.6 mil (5.1 to 15.2 microns) prepared in accordance withExample 2. The pouch was found to flush well even with a low-volumetoilet system (1.6 gal).

EXAMPLE 4

Another biodegradable film suitable for fabricating flushable ostomypouches was formed by heat-lamination of a plasticized biodegradablesynthetic polyester film having a thickness within the range of 0.4 to0.8 mil (10.2 to 20.3 microns) identified as “KF02B” from PetroplastVinora, Switzerland to a 100% cellulosic tissue having a basis weight of14 lb/ream (product code no. 3040 from Shawano Specialty Papers).

EXAMPLE 5

The improved biodegradability of a polyester film blended with abiodegradable plasticizer is illustrated by-this example.

Biodegradability was tested on film samples consisting of (1)polycaprolactone (“Tone 787” PCL from Dow Chemical) plasticized withtriethylcitrate (PCL/TEC weight ratio of 90/10), (2) unplasticized PCL(“Tone 787” from Dow Chemical) and (3) a control sample ofpolyvinylalcohol film taken from a commercially available flushableinner pouch product (“Impact” flushable ostomy bag from Welland MedicalLimited, Crawley, England). The films were exposed to aerobic sewagesludge inoculum in accordance with ASTM test method D-5209. The averageweight losses were (1) 64.0%, for the plasticized PCL, (2) 26.1% for theunplasticized PCL, and (3) 12.4% for the control sample.

The plasticized PCL therefore exhibited higher weight loss due tobiodegradation than the unplasticized PCL and much higher loss than thecommercial PVOH inner pouch material claimed by the manufacturer to bebiodegradable.

EXAMPLE 6

This example illustrates the conditions required to laminate a tissuepaper to a thin biodegradable film without causing pinhole formation inthe process.

A biodegradable film from Petroplast Vinora (KF02B, 20 microns thick)and a cellulosic tissue from Shawano Specialty Papers (Product Code3040, basis weight 14 lb/ream) were heat laminated using a Faustellaminator. The nip pressure was 50 psi, the temperature 220 degrees F.,and the line speed 35 to 40 feet per minute. The laminate exhibited a180 degree peel strength in the 3–6 g/in range.

The laminate was tested for pinholes as follows: A sample of thelaminate was laid on a flat surface with the film side facing up. A bluedye solution was applied on the surface of the film. After 5 minutes thefilm was turned over and the tissue side inspected. If pinholes werepresent, the dye solution would have wicked into the tissue producingvisible blue dots. The test showed no evidence of pinholes. As thelaminator line speed was decreased or the nip pressure increased, thepeel strength became progressively higher with evidence of residualfibers embedded in the film and pinholes appeared in the dye wickingtest.

EXAMPLE 7

This example illustrates the resistance to deformation imparted bytissue lamination to a thin biodegradable film.

The load at 1% and 2% strain was measured in accordance with ASTMD882-02 for the film-tissue laminate of Example 6 and for the film ofExample 6 without tissue. Results are illustrated in the followingtable:

Load @ 1% Load @ 2% Load @ 1% Load @ 2% strain, strain, strain, strain,MD (*) MD (*) TD (**) TD (**) lb/in lb/in lb/in lb/in Laminate of 0.841.48 0.83 1.35 Example 6 Film of 0.35 0.62 0.54 0.90 Example 6 (notissue) (*) MD: machine direction (**) TD: transverse direction

EXAMPLE 8

This example illustrates differences in heat sealing properties of filmssuitable for use in pouch-in-pouch appliances embodying the invention.Materials suitable for the walls of the inner pouch are heat-sealablebiodegradable films of 20 microns thickness of plasticized polyesterfrom Petroplast Vinora (KBF02B). A thermoplastic material suitable forthe walls of the outer pouch is a commercial multilayer barrier film forostomy pouches having a heat-sealable skin layer of EVA. In each test,two layers of the same film material were heat sealed together, orsought to be heat sealed together, for an interval of 1.2 seconds with asealing element maintained at different selected temperatures and at asealing pressure of 4 bar. Following cooling the strength of the seal(if any) was tested by manually peeling apart, or attempting to peelapart, the two layers. The results of such tests are given below:

Sealing Behavior/Observation 75 Micron Commercial Barrier Film with EVASkin Temperature Layer 20 Micron KF02B  80° C. — No Bonding  90° C. —Peel 100° C. — Peel 110° C. — Peel 120° C. No Bonding Peel 130° C. NoBonding Peel 135° C. Peel Full Seal 140° C. Peel — 150° C. Peel — 160°C. Peel — 170° C. Full Seal —

The term “Peel” as used in the chart means that the two layers hadlimited adherence to each other but could nevertheless be separated orpeeled apart with each layer remaining intact. “Full Seal” means thatthe layers had become welded or fused together and could not be soseparated. The chart reveals that the KF02B film had significantly lowerheat sealing temperatures than the control film. This is consistent withthe DSC melting temperatures discussed earlier.

While in the foregoing I have disclosed embodiments of the invention inconsiderable detail for purposes of illustration, it will be understoodby those skilled in the art that many of such details may be variedwithout departing from the spirit and scope of the invention.

1. A biodegradable body waste collection pouch particularly suitable for flush toilet disposability; said pouch having a pair of side walls secured together along their peripheral edges to define a waste-receiving chamber therebetween; one of said side walls having a waste-receiving opening therethrough communicating with said chamber; and external attachment means provided about said opening for attachment of said pouch to a wearer; said walls of said pouch being cut from a laminate composed of (a) a layer of thin heat-sealable film impermeable to liquid and solid body wastes and of a composition comprising a biodegradable aliphatic polyester, or a biodegradable aliphatic-aromatic copolyester, or blends thereof, plasticized by one or more biodegradable plasticizers and (b) a water-disintegratable biodegradable cover layer of water-dispersible fibers having one of its surfaces uninterruptedly bonded thereto; said film having a thickness no greater than about 40 microns; said layers of said laminate being weakly bonded together and separable from each other with each layer remaining intact by the application of 180-degree peeling forces in the range of about 2 to 10 g/in.
 2. The pouch of claim 1 in which said layers are separable from each other by the application of 180-degree peeling forces in the range of about 3 to 6 g/in.
 3. The pouch of claims 1 or 2 in which said plasticizer is selected from the group consisting of triethylcitrate, vegetable oil, and starch, and combinations thereof.
 4. The pouch of claims 1 or 2 in which said composition comprises a blend of about 70% to 95% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 5% to 30% by weight of said biodegradable plasticizer or plasticizers.
 5. The pouch of claim 4 in which said composition comprises a blend of about 75% to 93% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 7% to 25% by weight of one or more of said biodegradable plasticizer or plasticizers.
 6. The pouch of claim 5 in which said composition comprises a blend of about 90% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 10% by weight of said biodegradable plasticizer or plasticizers.
 7. The pouch of claims 1 or 2 in which said aliphatic polyester or the aliphatic component of said copolyester comprises a polymer formed by ring-opening polymerization of a lactone.
 8. The pouch of claims 1 or 2 in which said aliphatic-aromatic copolymer comprises a condensation product of a glycol with a combination of an aliphatic diacid and an aromatic diacid, wherein the aromatic diacid is less than 20% by mole.
 9. The pouch of claims 1 or 2 in which said film has a thickness within the range of about 10 to 35 microns.
 10. The pouch of claim 9 in which said film has a thickness within the range of about 15 to 30 microns.
 11. The pouch of claim 9 in which said film has a sound level no greater than about 51 dB in the 8 kHz octave band when said film is formed into a cylinder and mounted on a test fixture wherein one end is held fixed and the other end is rotated about the cylinder axis at 70 cycles/min and at 15° angles.
 12. The pouch of claim 9 in which said film has a secant modulus of less than about 45000 psi at 2% elongation when tested in accordance with ASTM D882-02.
 13. The pouch of claim 9 in which said film of a biodegradable aliphatic polyester or copolyester is a monolayer.
 14. The pouch of claim 1 in which said fibers of said water-disintegratable cover layer are cellulosic.
 15. The pouch of claim 14 in which said cover layer comprises tissue paper formed of 100% cellulosic fibers.
 16. The pouch of claim 1 in which said cover layer is heat-bonded to said film.
 17. A pouch-in-pouch body waste collection appliance comprising an outer pouch formed of liquid, gas and odor impermeable heat-sealable polymeric film having proximal and distal side walls defining a chamber; a toilet-disposable inner pouch having proximal and distal side walls and being disposed in said chamber; said proximal walls of said inner and outer pouches having aligned body waste receiving openings therethrough; and attachment means for attaching said proximal walls of said inner and outer pouches in areas surrounding said openings to skin surfaces of a patient about a body waste discharge orifice; said disposable inner pouch having walls formed from sheet material composed of (a) a layer of thin heat-sealable film impermeable to body wastes of a composition comprising a biodegradable aliphatic polyester, or a biodegradable aliphatic-aromatic copolyester, or blends thereof, plasticized by one or more biodegradable plasticizers and (b) a water-disintegratable, porous, biodegradable cover layer of water-dispersible fibers bonded thereto; said heat-sealable film of said inner pouch having a melting temperature lower than that of the heat-sealable film of said outer pouch; said walls of said outer and inner pouches having peripheral edge portions heat-sealed together with the peripheral edge portions of said cover layer being bonded more securely to the film material of said inner pouch than to the film material of said outer pouch.
 18. The body waste collection appliance of claim 17 in which said film of said outer pouch has a melting temperature at least 10 degrees C. higher than the melting temperature of said heat-sealable inner pouch film.
 19. The body waste collection appliance of claims 17 or 18 in which said composition comprises a blend of about 70% to 95% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 5% to 30% by weight of said biodegradable plasticizer.
 20. The body waste collection appliance of claim 19 in which said composition comprises a blend of about 75% to 93% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 7% to 25% by weight of said biodegradable plasticizer.
 21. The body waste collection appliance of claim 20 in which said composition comprises a blend of about 90% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 10% by weight of said biodegradable plasticizer.
 22. The body waste collection appliance of claims 17 or 18 in which said aliphatic polyester or the aliphatic component of said copolyester comprises a polymer formed by ring-opening polymerization of a lactone.
 23. The body waste collection appliance of claims 17 or 18 in which said aliphatic-aromatic copolymer comprises a condensation product of a glycol with a combination of an aliphatic diacid and an aromatic diacid, wherein the aromatic diacid is less than 20% by mole.
 24. The body waste collection appliance of claims 17 or 18 in which said film of said inner pouch has a thickness no greater than about 40 microns.
 25. The body waste collection appliance of claim 24 in which said film has a thickness within the range of about 10 to 35 microns.
 26. The body waste collection appliance of claim 25 in which said film has a thickness within the range of about 15 to 30 microns.
 27. The body waste collection appliance of claims 17 or 18 in which said fibers of said water disintegratable cover layer are cellulosic.
 28. The body waste collection appliance of claim 27 in which said cellulosic fiber cover layer comprises tissue paper.
 29. The body waste collection appliance of claim 28 in which said tissue paper is 100% cellulosic fibers.
 30. A pouch-in-pouch body waste collection appliance comprising an outer pouch formed of liquid, gas and odor impermeable heat-sealable polymeric film having proximal and distal side walls defining a chamber; a toilet-disposable inner pouch having proximal and distal side walls and being disposed in said chamber; said proximal walls of said inner and outer pouches having aligned body waste receiving openings therethrough; and attachment means for attaching said proximal walls of said inner and outer pouches in areas surrounding said openings to skin surfaces of a wearer about a body waste discharge orifice; said disposable inner pouch having walls formed of (a) a layer of a heat-sealable film impermeable to body wastes having a thickness no greater than about 40 microns and of a composition comprising a biodegradable aliphatic polyester, or a biodegradable aliphatic-aromatic copolyester, or blends thereof, plasticized by one or more biodegradable plasticizers and (b) a water-disintegratable, porous, biodegradable cover layer of water-dispersible fibers having substantially an entire surface of said cover layer, except for its peripheral edges, weakly bonded to said inner pouch film; said weak bond permitting separation of said surface of said cover layer from said inner pouch film, with both remaining substantially intact, by the application of 180 degree peeling forces in the range of about 2 to 10 g/in.
 31. The appliance of claim 30 in which said weak bond permits separation of said surface of said cover layer from said inner pouch film, with both remaining substantially intact, by the application of 180 degree peeling forces in the range of about 3 to 6 g/in.
 32. The appliance of claims 30 or 31 in which said composition comprises a blend of about 70% to 95% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 5% to 30% by weight of said biodegradable plasticizer.
 33. The appliance of claim 32 in which said composition comprises a blend of about 75% to 93% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 7% to 25% by weight of said biodegradable plasticizer.
 34. The appliance of claim 32 in which said composition comprises a blend of about 90% by weight of said biodegradable aliphatic polyester or aliphatic-aromatic copolyester and about 10% by weight of said biodegradable plasticizer.
 35. The appliance of claims 30 or 31 in which said aliphatic polyester or the aliphatic component of said copolyester comprises a polymer formed by ring-opening polymerization of a lactone.
 36. The appliance of claims 30 or 31 in which said aliphatic-aromatic copolymer comprises a condensation product of a glycol with a combination of an aliphatic diacid and an aromatic diacid, wherein the aromatic diacid is less than 20% by mole.
 37. The appliance of claims 30 or 31 in which said film of said inner pouch has a thickness within the range of about 10 to 35 microns.
 38. The appliance of claim 37 in which said film of said inner pouch has a thickness within the range of about 15 to 30 microns.
 39. The appliance of claims 30 or 31 in which said fibers of said cover layer are cellulosic.
 40. The appliance of claim 39 in which said cellulosic fiber cover layer comprises tissue paper. 